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New Jersey Physician Magazine
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Also in this Issue• New Jersey Bill Provides for Facilities to Make Health Care Decisions for
Patients without Decision Making Capacity
• Update on Appeals Court decisions regarding the Federal Health Reform Law
• Medical Protective to Acquire Princeton Insurance
• Emerging Liability Insurance Risks
Michael C. Pitter, MDPioneering the Adoption of Robotic-Assisted Surgery for Minimally Invasive Treatment of Benign Gynecologic Conditions
s e p t e m b e r 2 0 11
www.HNManagement.com973-660-9334/ext 125Located in Florham Park, NJ
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Publisher’s Letter
Dear Readers,
Welcome to the September edition of New Jersey Physician, the provider of
critical information for the state’s medical community.
When a person loses the decision-making capacity, a new bill will provide for
facilities to make health care decisions for these patients. The health care facility
will be authorized to designate a surrogate to make these decisions. If passed in
its present form, the new law would establish a three year transition authorization
panel demonstration program, to be conducted at six program sites for the
purpose of evaluating an approach to making decisions relating to the transition
of eligible patients from inpatient care to post-acute care.
In response to the federal health reform law, now known as the Affordable Care
Act, and separate state reform initiatives, some members of at least 45 state
legislatures have proposed legislation to limit, alter or oppose selected state
or federal actions. Recent conflicting state decisions and resulting conflicting
decisions by federal appeals courts make it appear likely that the ACA is heading
to the Federal Supreme Court.
Medical Liability Mutual Insurance Company, parent of Princeton Insurance, and
Medical Protective Company, a Berkshire Hathaway subsidiary have announced
they have entered into a definitive agreement for the sale of Princeton Insurance
Company, one of the Northeast’s premiere professional liability insurers.
We are pleased and proud to introduce a new column in this month’s issue.
Leon Smith, MD, one of the most well known and respected infectious disease
specialists in New Jersey will be submitting most interesting case histories and
asking physicians to submit a diagnosis. Correct responses will win a New Jersey
Physician T-Shirt as well as receiving mention in the following month’s column.
Take a look at this new feature and give it a try by responding to me by email.
Our cover story this month profiles Michael C. Pitter, MD. Dr. Pitter is well-known
and internationally respected gynecologic surgeon who has pioneered the
use of the da Vinci® robotic system for minimally invasive treatment of benign
gynecologic conditions. With his significant experience in the use of the system,
he has demonstrated that robotic assistance facilitates the laparoscopic approach
and can provide an improved rate of minimally invasive surgery adoption
by gynecologists with outcomes that are equivalent to conventional open
techniques.
With warm regards,
Michael GoldbergCo-Publisher
New Jersey Physician Magazine
Published by Montdor Medical Media, LLC
Co-Publisher and Managing EditorsIris and Michael Goldberg
Contributing Writers Iris GoldbergLeon Smith, MDLani M. Dornfeld, EsqKevin M. Lastorino, EsqBrian Kern, Esq
New Jersey Physician is published monthly by montdor medical media, LLC.,PO Box 257Livingston NJ 07039Tel: 973.994.0068Fax: 973.994.2063
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Physician, please contact Iris Goldberg at
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of NJ Physicians Association
2 New Jersey Physician
CONTENTS
10
Health Law Update
12
Statehouse
14
Medical Malpractice
Emerging liability insurance risks
16
Industry News
Medical Protective to acquire Princeton Insurance
17
Diagnosis
Choose the correct diagnosis to the given symptoms and you could win
18
Food for Thought
Arturo’s - Osteria & Pizzeria Maplewood, New Jersey
20
Hospital Rounds
Contents
Michael C. Pitter, MDPioneering the Adoption of Robotic-Assisted Surgery for
Minimally Invasive Treatment of Benign Gynecologic Conditions
COVER STORY
4
Call for NomiNatioNs
New Jersey physician magazine invites all medical practices to submit nominations for cover stories.
practices should include a brief description of what makes the practice special.
please contact the publisher Iris Goldberg at [email protected]
September 2011 3
4 New Jersey Physician
Although a minimally invasive
laparoscopic approach is routinely
utilized for many commonly performed
surgeries within a cross-section of
specialties, for some predominant
gynecologic procedures, a pure
laparoscopic approach is difficult to master
for the average gynecologist. The technique
of laparoscopic suturing required for these
procedures has proven to be extremely
challenging for a great many gynecologists
and has been mastered by only a relatively
small number of minimally invasive
gynecologic surgeons.
With robotic assistance, however, the
difficulties of a pure laparoscopic approach
can be overcome and these procedures
can be performed in a minimally invasive
manner. Michael C. Pitter, MD is the
chief of gynecologic robotic and minimally
invasive surgery and a clinical assistant
professor of obstetrics and gynecology
at Newark Beth Israel Medical Center
and is affiliated with Hackensack University Medical Center as well.
Dr. Pitter specializes in robot-assisted
minimally invasive surgery for the
treatment of benign gynecologic
conditions. He discusses, from his
significant experience with the da Vinci®
Surgical System, how robotic assistance
facilitates the laparoscopic approach and
can provide an improved rate of minimally
invasive surgery adoption by gynecologists
with outcomes that are equivalent to
conventional techniques.
Cover Story
Michael C. Pitter, MDPioneering the Adoption of Robotic-Assisted Surgery for Minimally Invasive Treatment of Benign Gynecologic Conditions By Iris Goldberg
p Dr. pitter is at the controls of the da Vinci® robot. robotic assistance facilitates the laparoscopic approach and provides an improved rate of minimally invasive surgery adoption.
September 2011 5
“The addition of the da Vinci® system to laparoscopy really makes
these procedures almost like open surgery through laparoscopic
access. In any suture-intensive operation, where you are trying to
replicate the motions of the human hand, the da Vinci® system
is definitely an enabling tool for the average surgeon to be able to
do those procedures without having to have an extensive learning
curve,” Dr. Pitter shares.
Myomectomy is an alternative to hysterectomy for the removal of
uterine fibroid tumors whether or not future fertility is an issue. Dr.
Pitter shares that with increased awareness on the part of patients,
myomectomy is often the more desirable option for women of all
ages, preferring to opt for the minimally invasive approach.
Uterine fibroids are benign tumors that originate in the uterus.
Although they are composed of the same smooth muscle fibers as
the myometrium (uterine wall), they are many times denser. Usually
round or semi-round in shape, uterine fibroids are often described
based on their location within the uterus. Subserosal fibroids are
located beneath the serosa (lining membrane on the outside of
the organ). These often appear localized on the outside surface of
the uterus or may be attached to the outside surface by a pedicle.
Submucosal fibroids are located inside the uterine cavity beneath
the lining of the uterus. Intramural fibroids are located within the
muscular wall of the uterus.
Fibroid tumors are quite common with up to 70 percent of women
developing fibroids by age 55. Dr. Pitter explains that only a small
percentage of women with uterine fibroids are symptomatic. Of those,
perhaps 40 to 50 percent will experience bleeding and pain.
The treatment options vary depending upon the size of the tumor, the
symptoms and the age of the patient. When fibroids are very small
and are not causing significant symptoms, the patient can merely
be watched over time. When pain and/or bleeding result or when a
woman’s fertility is impacted by uterine fibroids, it becomes necessary
to remove them.
“There is a lot of work that has been done and published looking at
pregnancy rates with and without fibroids. We know that when these
fibroids are removed, pregnancy rates go up,” Dr. Pitter reports. In fact,
Dr. Pitter sees many women who have been referred by reproductive
endocrinologists. Even if IVF is still on the horizon, removal of fibroids
will enhance the chances that conception will occur. “In women for
whom fertility is not an issue, myomectomy can result in resolution
of symptoms (decreased pain and bleeding) in up to 81 percent of
patients,” Dr. Pitter continues.
The technique chosen depends on location, number and size of the
fibroids and the expertise of the surgeon. For fibroids that are less
than 5 cm. and are located in the sub-mucosa or lining of the uterus,
Dr. Pitter would most likely employ a hysteroscopic or trans-vaginal
approach. For fibroids that are greater than 5 cm. the options are:
a multi-stage (repeating the procedure on more than one occasion)
hysteroscopic approach, a conventional open procedure or a
laparoscopic approach.
“The problem with traditional laparoscopy is that when you have a
fibroid that is five or more centimeters in diameter and it is deeply
embedded within the myometrium, it is very difficult to gain access.
Those tumors require a multi-layer closure in order to ensure adequate
healing, especially in women for whom fertility is an issue,” explains
Dr. Pitter.
To successfully perform a multi-layer closure to repair deep
hysterotomy defects with the rigid instruments used in traditional
laparoscopy and also to master the skill sets required for endoscopic
suturing and tying of knots to obtain a tight, secure hemostatic
closure is possible with pure laparoscopy, according to Dr. Pitter
but extremely challenging for the average surgeon. When the robot
is added, however, he knows without question that the robotic
platform gives surgeons greater capability of successfully repairing
deep hysterotomy defects and provides them with a more achievable
minimally invasive option to offer patients.p the robotic arms are in place to begin the myomectomy. below, Dr. pitter views mrI mapping which shows the number and location of fibroids to be removed.
p One of the fibroids is being removed.
6 New Jersey Physician
After successfully completing a difficult purely laparoscopic
myomectomy about six years back and really struggling to replicate
the results that would be achieved in an open procedure, Dr. Pitter
happened to see a da Vinci® robotic prostatectomy that was being
performed in the OR next to his. The urologic surgeon was still in the
process of being trained to operate the robot. “That’s when the light
bulb really went off in my mind,” Dr. Pitter remembers. He thought to
himself, “This thing has wrists. It can suture. What would happen if I
used this for my myomectomy procedures?”
Dr. Pitter approached the representative from Intuitive, which is the
company that developed the da Vinci® Surgical System and asked
how he might receive training. Things moved quickly after that. He
received his initial training in a porcine lab, where animal models are
used. “I knew immediately this was the right thing for me,” Dr. Pitter
relates. He soon became convinced that other gynecologic surgeons
could benefit from this technology without needing an extensive
amount of time to adapt.
In fact, four years ago Dr. Pitter wrote a paper that questioned how
steep the learning curve would be for the average surgeon to gain
proficiency with the robot. He reported that after only about 20
procedures there was a significant drop in blood loss and operating
time. These results were duplicated in subsequent studies by other
researchers.
When a woman has fibroids that are exceptionally large or when there
are multiple fibroids to be removed, Dr. Pitter reports that traditionally,
she would have an open abdominal procedure instead of a minimally
invasive laparotomy because that would be the safest and most
direct approach for successful removal of the tumor or tumors in the
shortest amount of time.
Again, as Dr. Pitter emphasized, the robot-assisted myomectomy
combines the best of open and laparoscopic surgery. With this
technology surgeons can remove uterine fibroids using a minimally
invasive approach through small incisions with unmatched precision
and control. Comprehensive and thorough reconstruction of the
uterine wall, regardless of the size or location of fibroids is achieved.
This is important in preventing possible uterine rupture for those
women who will become pregnant in the future.
“We have noticed that as surgeons gain more experience with the
robot, we are now able to remove multiple fibroids with fibroid volumes
comparable to open abdominal myomectomies,” Dr. Pitter informs.
The incorporation of magnetic resonance imaging (MRI) into robotics
has helped to compensate for the absence of tactile feedback. 3-D MR
images, displayed on the surgeon’s console are used for mapping,
detecting, locating and enucleating myomas (fibroids). The capability
to see all three views – axial, coronal and sagittal – during surgery
enables Dr. Pitter to overcome tactile limitations and remove multiple
myomas.
MR imaging can also be used as a preoperative tool to determine prior
to surgery, the size, number and location of myomas. MRI mapping of
fibroids is a new technology which Dr. Pitter has recently implemented
into his procedures and is teaching to other surgeons. For fibroids that
are situated deep into the myometrium, especially, this technology
prevents those fibroids from being missed by the surgeon. “By having
the three dimensional coordinates of exactly where all the fibroids are,
I am able provide complete treatment and remove all of the fibroids
without actually feeling them,” Dr. Pitter explains.
Another important advantage of MRI mapping that Dr. Pitter mentions
is the ability to find all the fibroids quickly which cuts down on
operating time and blood loss. Knowing exactly where the fibroids
are also eliminates unnecessary probing of healthy tissue.
Having the MRI prior to surgery helps to determine whether a
patient is a good candidate for myomectomy or perhaps should be
disqualified due to the number and location of her myomas. In an
article written by him that appeared in the June, 2011 issue of Ob.Gyn.
News, Dr. Pitter says, “In my experience, MR imaging can be useful
preoperatively in conjunction with pelvic exams to effectively screen
for patients who are likely to have successful outcomes with robotic
myomectomy.”
p Here the robot enables a secure hemostatic closure to successfully repair hystertomy defects.
p the incorporation of mrI imaging helps surgeons compensate for the absence of tactile feedback.
September 2011 7
The three basic components of the da Vinci® system are a patient-
side cart, a vision system and a surgeon’s console. The patient-side
cart has four robotic arms that are attached or “docked” to trocars that
are placed in the abdomen in strategic locations. One arm holds the
endoscope (either an 8.5-mm or 12-mm diameter, with a 0-degree or
30-degree configuration) and the other three arms hold miniaturized
8-mm (or 5-mm) instruments. The vision system delivers a high-
definition 3D image to the viewer in the surgeon’s console and 2-D
images to other monitors in the operating room.
From the console, the surgeon uses hand controllers and foot pedals
to move the instrument and camera robotic arms of the patient-
side cart via a process of computer algorithms that reduce tremor
and employ motion scaling to deliver precise movements within the
surgical field. The robotic instruments have seven degrees of freedom
that replicate or surpass the motions of the human hand, allowing the
surgeon to essentially perform open surgery through laparoscopic
access.
Besides myomectomy, there are other commonly performed
gynecologic procedures to treat benign conditions that are well-
suited to robotic assistance. Sacrocolpopexy is surgery to correct
any pelvic floor prolapse where the entire vagina or the uterus, cervix
and vagina are protruding out of the body. This reconstruction of the
pelvic floor is accomplished with and without the use of mesh or any
other tethering tools. More than 120,000 women in the United States
undergo sacrocolpopexy each year.
Prolapse (falling) of the pelvic floor organs (vagina, uterus, bladder or
rectum) occurs when the connective tissues or muscles in the body
cavity are weak and cannot hold the pelvis in its natural position. The
weakening of connective tissues accelerates with age, after childbirth,
with weight gain or strenuous physical activity. Women with pelvic
floor prolapse experience problems with urinary incontinence,
vaginal dysfunction and/or difficulty with bowel movement.
Traditional open sacrocolpopexy, which involves a 15-30 cm horizontal
incision in the lower abdomen and a lengthy and bloody procedure to
manually access the inter-abdominal organs, including the uterus was
the gold standard. Dr. Pitter shares that much like for myomectomy,
performing a straight laparoscopic sacrocolpopexy, which is another
suture intensive procedure, without robotic assistance is tedious and
presents a considerable challenge.
With the introduction of the da Vinci® robot to sacrocolpopexy, a
laparoscopic, minimally invasive approach with small incisions can
now be used to make the repair. The robotic instruments are employed
in the same manner as in myomectomy, allowing the benefits of open
surgery through laparoscopic access, thereby reducing the risk of
complications associated with the open procedure.
In fact, in a chapter in the September, 2011 issue of Clinical
Obstetrics & Gynecology, which Dr. Pitter co-authored, it was
reported that when comparing the learning curve for straight
laparoscopic sacrocolpopexy with that of robot-assisted laparoscopic
sacrocolpopexy, the difference was staggering. The robotic procedure
has been consistently significantly easier for surgeons to adopt.
In addition to the difficulties faced by surgeons attempting to perform
a purely laparoscopic myomectomy or sacrocolpopexy, Dr. Pitter
discusses the troubled history of laparoscopic hysterectomy. He
relates that since the first description of laparoscopic hysterectomy
p the da Vinci® robot stands next to the patient during the procedure. Dr. pitter is operating the controls from the console.
p Dr. pitter is beginning a robot assisted hysterectomy by placing the laparoscope into the abdomen to ensure proper placement of the trocars.
8 New Jersey Physician
in the late 1980s, although there were slight increases in the 20 years
following, only about 12-14 percent of all hysterectomies performed
were done laparoscopically due to the challenges of a straight
laparoscopic approach.
Dr. Pitter cites the most recent mission statement by the American
Association of Gynecologic Laparoscopists (AAGL) at their last
meeting in November. Basically, the Association stated that if a woman
requires a hysterectomy for a benign condition, then that procedure
should be done vaginally or laparoscopically. The statement continues
to advise that if a surgeon is not capable of doing that, then he or she
should refer that patient to a surgeon who is.
(Pitter 9)
Most interesting, Dr. Pitter shares, is that in the five or six years since
the introduction of the da Vinci® Surgical System into gynecologic
surgery, 20 percent of hysterectomies are now being done through a
robot-assisted laparoscopic procedure. “It’s really making a difference
in terms of being able to provide a minimally invasive alternative to
women who need this procedure for benign indications,” Dr. Pitter is
happy to report.
Dr. Pitter receives referrals from the tri-state area and also nationally and
internationally for each of the robot-assisted procedures he performs.
Endocrinologists, internists, urologists and even gynecologists who
do not perform laparoscopic surgeries, send their patients to Dr. Pitter
for surgical treatment that is minimally invasive. After surgical care
has been completed, those patients return to their own physicians.
As a pioneer of robot-assisted gynecologic surgery, Dr. Pitter teaches
other surgeons, nationally and internationally, who wish to adopt the
da Vinci® system for their procedures. He also serves as a consultant,
meeting with engineers to help fine-tune tools for gynecologic
robotic surgery that are already in development and those that are
being developed. Additionally, Dr. Pitter advises on the creation of
educational devices such as simulators for surgeons in training. For
gynecologic surgeons who have already adopted the da Vinci®
system, Dr. Pitter is one of the hosts who teach courses at increasing
levels that help even those who have done more than 100 robot-
assisted laparoscopic surgeries to further hone their skills.
There is no question that a laparoscopic approach, which offers
a much lower rate of associated complications, is superior to
open surgery whenever there is a choice. For women with benign
gynecologic conditions, Dr. Pitter has been instrumental in ensuring
that minimally invasive surgery becomes increasingly more available
as an option.
For more information or to make an appointment with Dr. Pitter, please
call (973) 926-4600.
p the robot is used to separate and free the uterus.
p As a pioneer of robot-assisted gynecologic surgery, Dr. pitter teaches surgeons nationally and internationally who wish to adopt the da Vinci® system. He has been instrumental in increasing the adoption of the da Vinci® system for the treatment of benign gynecologic conditions.
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10 New Jersey Physician
Health Law Update
OIG Identifies $6.8 Million in Overpayments to NJ and Surrounding States
HealtH lawUpdateProvided by Brach Eichler LLC, Counselors at Law
On August 17, 2011, the U.S. Department of
Health & Human Services Office of Inspec-
tor General (OIG) released an audit report
detailing Highmark Medicare Services over-
payments. According to the OIG, providers
were overpaid by approximately $6.8 mil-
lion from January 1, 2006 through June 30,
2009.
The OIG found that 68% of 1,507 selected
claims processed by Highmark, the Medi-
care Administrative Contractor for Pennsyl-
vania, Delaware, Maryland, New Jersey and
the District of Columbia metro area, were
incorrectly paid for outpatient services.
Moreover, the OIG reported that providers
failed to refund any of the overpayments by
the start of the OIG’s investigation.
Additional billing issues highlighted in the
report include the following:
• Incorrect units of service
• Packaged services billed separately
• Healthcare Common Procedure Coding
System (HCPCS) codes that did not re-
flect the procedures performed
• Unallowable services
• Unlabeled use of a drug/biological
• A lack of supporting documentation
• A combination of incorrect units of ser-
vice and incorrect HCPCS codes
• Incorrectly calculated payments
The OIG recommended that Highmark re-
cover the identified overpayments, imple-
ment system edits that identify line item
payments that exceed billed charges by a
prescribed amount, and utilize the results
of the audit report in its provider education
activities.
New Jersey Bill Provides for Facilities to Make Health Care Decisions for Patients Without Decision-Making CapacityOn June 13, 2011, a bill sponsored by As-
semblyman Herb Conaway, Jr. and Assem-
blywoman Valerie Vainieri Huttle reported
favorably out of the Assembly Health and
Senior Services Committee (A4098). The
impetus behind the bill is to facilitate the
making of health care decisions for patients
in a general or special hospital, nursing
home or assisted living facility (health care
facility) who have lost decision-making ca-
pacity, and to establish a demonstration
program relating to the transfer of certain
patients from inpatient care to post-acute
care.
Some of the major highlights of the bill in-
clude:
• A health care facility will be required to
establish policies and procedures to pro-
vide for the making of health care deci-
sions by a surrogate, to be designated by
the health care facility, for an adult pa-
tient who is determined to lack decision-
making capacity, who does not have a
patient’s representative and who has not
executed an advance directive
• The patient’s attending physician will
make an initial determination (subject to
a concurring determination by a health
or social service practitioner) that the
patient lacks decision-making capacity to
a reasonable degree of medical certainty,
including an assessment of the cause
September 2011 11
and extent of the patient’s incapacity and
the likelihood that the patient will regain
decision-making capacity
• A health care facility will be authorized to
designate a surrogate to make health care
decisions for an adult patient who has
been determined to lack decision-making
capacity, and is to provide prompt notice
of that determination and designation to
the patient, if the health care facility has
any indication of the patient’s ability to
comprehend the information, and at least
one person on the “surrogate list,” which
will be set forth in the final law and which
will designate individuals, by order of
priority, to be named as surrogates when
necessary
• A surrogate who is designated pursuant to
the bill will, subject to the provisions to be
included in the final law, have authority to
make health care decisions on the adult
patient’s behalf
• A decision by a surrogate to withhold or
withdraw life-sustaining treatment from
the patient will be authorized if the at-
tending physician determines, with the
independent concurrence of another
physician and to a reasonable degree of
medical certainty and in accordance with
accepted medical standards, that certain
criteria to be set forth in the final law are
met
If passed in its present form, the new law
would establish a three-year transition au-
thorization panel demonstration program,
to be conducted at six program sites, two
each in the northern, central and southern
regions of the state, for the purpose of evalu-
ating an approach to making decisions relat-
ing to the transition of eligible patients from
inpatient care to post-acute care.
We will continue to monitor the progress of
this bill as it continues through the legisla-
tive process.
For additional information, contact: Lani
M. Dornfeld 973.403.3136 ldornfeld@
bracheichler.com or Kevin M. Lastorino
973.403.3129 [email protected]
Princeton Insurance knows New Jersey, with the longest continuous market
presence of any company offering medical professional liability coverage in the state.
Leadership: Over 16,000 New Jersey policyholders
Longevity: Serving New Jersey continuously since 1976
Expertise: More than 55,000 New Jersey medical malpracticeclaims handled
Strength: Over $1 billion in assets and $353 million in surplusas of December 31, 2010
Service: Calls handled personally, specialized legalrepresentation, knowledgeable independent agents,in-office visits by our skilled risk consultants
Knowledge: New Jersey-specific knowledge and decades of experience
Innovation: Three corporate options, specialty reports,practitioner profiles, office practice toolkits, optional data privacy coverage
12 New Jersey Physician
Statehouse
NEW JERSEYSTaTEHOUSE
In response to the federal health reform
law, now known as the Affordable Care Act
(ACA), and separate state reform initiatives,
some members of at least 45 state legislatures
have proposed legislation to limit, alter or
oppose selected state or federal actions. In
general many of the opposing measures, in
2010 and 2011:
• Focus on not permitting, implementing or
enforcing mandates (federal or state) that
would require purchase of insurance by
individuals or by employers and impose
fines or penalties for those who fail to do so.
• Seek to keep in-state health insurance
optional, and instead allow people to
purchase any type of health services or
coverage they may choose.
• Contradict or challenge policy provisions
contained in the 2010 federal law.
The language varies from state to state
and includes statutes and constitutional
amendments, as well as binding and non-
binding state resolutions. For 2011, there are
several new approaches:
• Several states considered bills that would
prohibit state agencies or officials from
applying for federal grants or using state
resources to implement provisions of the
Affordable Care Act, unless authorized to
do so by adopted state legislation.
• 16 states considered measures to create
an “Interstate Freedom Compact,” joining
forces across state lines to coordinate
or enforce opposition; four states now
have enacted laws. For information, see
NCSL article: Some States Pursue Health
Compact (Updated edition 7/19/2011).
• Several states are considering bills that
propose the power of “nullification,”
seeking to label the federal law “null and
void” within the state boundaries.
Florida v. U.S. Dep’t of Health & Human
Services. On September 28 both the
plaintiffs and the Justice Department, in
the Florida-based multi-state challenge to
the Affordable Care Act (ACA), formally
petitioned the Supreme Court to take up
the case during its upcoming term (October
2011-June 2012).
“We believe the question is appropriate for
review by the Supreme Court,” the Justice
Department stated on Wednesday. “Time is
of the essence,” wrote Paul D. Clement, the
former United States solicitor general who
represents 26 states that are challenging
the law. On September 26, the Justice
Department said that it had decided not to
ask the full U.S. Court of Appeals for the 11th
Circuit in Atlanta to conduct another review
at the circuit court level, which could have
slowed the court process.
On August 12, the Court of Appeals for the
11th Circuit in Atlanta, in State of Florida v.
U.S. Dep’t of Health & Human Services, ruled
against the individual mandate provision in
the ACA, by 2-to-1. This case was initiated
by Florida A.G. Bill McCollum and eventually
joined by 26 states; their case argued that the
reform law should be struck down because
it relies on an unconstitutional expansion of
federal power.
Court Filings requesting Surpreme Court
review: United States’s petition for a writ of
certiorari | Florida et al. petition for a writ
of certiorari | NFIB petition for a writ of
certiorari 9/28/2011.
News analyses: “Supreme Court Is Asked to
Rule on Health Care” by New York Times,
9/29/2011
affordable Care act
appeals Court action with Leagal Details
September 2011 13
Statehouse
Let Brach Eichler’s Health Law Practice Group Help You Chart a Strategic Course For Your Health Care Business
Health care providers have long come to rely on the attorneys of Brach Eichler to navigate the regulatory environment at both the state and federal levels. Now that health
care reform is being implemented, Brach Eichler is ready to help you make sense of the significant changes, the statutory framework
and the ramifications for health care providers in New Jersey.
Todd C. BrowerLani M. Dornfeld
John D. FanburgJoseph M. Gorrell
Carol GreleckiKevin M. Lastorino
Debra C. LienhardtMark Manigan
Health Law Practice Group
Richard B. RobinsJenny CarrollChad D. Ehrenkranz
Lauren FuhrmanEric W. GrossRita M. Jennings
Leonard LipskyIsai SenthilEdward J. Yun
101 Eisenhower Parkway • Roseland, New Jersey 07068 • t. 973.228.5700 • f. 973.228.7852 • www.bracheichler.com
Virginia: On September 8, 2011, the U.S.
Court of Appeals for the Fourth Circuit in
Richmond, Virginia sided with the federal
health reform law on procedural grounds,
dismissing or “vacating” two separate earlier
District Court cases.
• In Commonwealth of Virginia v.
Kathleen Sebelius (#11-1057), the
Appeals Court judges’ opinion (33 pages)
ruled that Virginia did not have standing
to challenge the Affordable Care Act based
on their state statute (Virginia Chapter
106 of 2010) declaring opposition to an
“individual mandate.” The federal law
will require most Americans to obtain or
purchase health insurance by 2014 or face a
financial penalty. The unanimous opinion,
written by Judge Diana Gribbon Motz,
concluded that a state does not “acquire
some special stake in the relationship
between its citizens and the federal
government merely by memorializing its
litigation position in a statute.” (p. 28) She
continued, “If we were to adopt Virginia’s
standing theory, each state could become
a roving constitutional watchdog of sorts.”
In both cases, the decision was to “vacate the
judgment of the district court and remand to
that court, with instructions to dismiss the
case for lack of subject-matter jurisdiction.”
Virginia goes back to the U.S. District Court
for the Eastern District of Virginia; (Civil
Action No. 3:10-cv-188,) where Judge Henry
Hudson had issued a ruling on December
13, 2010, declaring the federal individual
mandate unconstitutional. Virginia Attorney
General Kenneth Cuccinelli announced on
September 8 that he would appeal to the U.S.
Supreme Court.
• In Liberty University v. Timothy
Geithner (#10-2347), the Appeals Court
judges’ opinion (140 pages) ruled 2-1
that the plaintiffs also lacked standing to
challenge the federal law, for a different
legal reason. Judge Motz wrote that the
Liberty suit could not seek to strike down
the individual mandate before it took effect
in 2014 because doing so would, in effect,
usurp the government’s right to collect a tax.
Earlier, another federal appeals court
disagreed when reviewing similar but
separate legal challenges, upholding the
Affordable Care Act.
• Ohio: On June 29, a three-judge panel of
the Court of Appeals for the Sixth Circuit in
Cincinnati, in Thomas More Law Center
v. Barack Obama (#10-2388), ruled 2-to-
1 in favor of the federal law’s requirement
that most Americans must obtain health
insurance, starting in 2014. Judge Jeffrey
Sutton delivered the opinion for the court;
the decision in part split three ways, with
no majority to completely uphold the
mandate under the Commerce Clause.
14 New Jersey Physician
Medical Malpractice
Emerging Liability Insurance RisksWhile the healthcare provider landscape
changes, so too does the healthcare liability
insurance landscape. Physicians who are
selling their practices, or partnering or
working with larger systems are sometimes
encouraged to accept anew liability
insurance plan. Other physicians are being
approached by representatives touting
the latest concepts in professional liability
insurance. With new plans though, come
new issues, and sometimes, new lawsuits.
To avoid litigation tomorrow, physicians
should be asking five essential questions
today.
1) What Type of Coverage Will I Have?The two main types of professional liability
insurance coverage are occurrence
and claims-made. Occurrence coverage
provides “permanent” protection, as long
as coverage is in place when a
covered incident that
leads to a claim
occurs.
Claims-made coverage requires a policy
to be in effect both at the time an incident
that leads to a claim occurs, and at the
time the claim is made. Therefore, if there
is any interruption, lapse, or termination in
coverage, some claims may not be covered.
Some examples of prior cases, which
involve claims-made policies that have led
to denials of coverage, include:
- Expiration of extended reporting (“tail”)
coverage prior to a claim being made.
- Failure to align retroactive dates when
changing carriers.
If coverage is claims-made, physicians
should confirm, in writing, the terms of
the tail.
2) What are My Claim Reporting Obligations?Reporting obligations under an occurrence
policy are relatively flexible, as coverage is
triggered based upon the occurrence of an
event, not the reporting of an incident or
claim. Nevertheless, physicians should err
on the side of caution, and always consult
their personal attorneys or brokers - prior
to contacting a carrier - when an adverse
event occurs.
Reporting requirements under a claims-
made policy are generally stricter, especially
if a physician is changing carriers. Before
changing carriers, physicians should
report, and verify, coverage for any adverse
incidents. Even when physicians are
not changing carriers, it is important to
understand what circumstances give rise
to a “claim,” and when they should be
reported.
September 2011 15
Notably, there are variations on claims-
made policies, such as “claims-made
and reported” policies, which preclude
coverage for any adverse incident that
could reasonably lead to a claim if it is not
reported before the policy renews. Many
problems can arise when physicians switch
policies without performing sufficient due
diligence. Examples include:
- When switching carriers, not notifying
both carriers of a potential claim.
- Notifying a carrier of a claim, but not
getting confirmation of coverage.
- Not reporting a claim to a carrier prior to
renewing a policy.
When an adverse incident occurs, physi-
cians should always contact their legal
advisor(s).
3) Is My Tail Guaranteed? By Whom? Even if an employer provides coverage to
an employee while he or she is working
on its behalf, this does not guarantee that
coverage will remain in place after the
employment relationship ends. In one
recent NJ decision, a court essentially held
that an employer is not responsible for an
employee’s tail coverage in the absence
of contractual language to that effect.
Therefore, the burden is on physician-
employees to ensure that their coverage
survives post-employment.
Significantly, some liability insurance
programs do not even allow individual
physicians to address tail coverage upon the
termination of an employment relationship,
and are beholden to the employer to ensure
that coverage remains in force.
For example, if a medical group has a
“blanket” claims-made policy that covers all
employed-healthcare providers, the group
alone is responsible for renewing the policy
every year. If the group fails to renew the
policy, the policy can cancel without the
physician having the ability to obtain his or
her own tail.
Examples of tail issues that can occur:
- A hospital system declares bankruptcy
and cannot meet its insurance payment
obligations, so coverage for itself and all
employees terminates.
- Other physicians within an insurance
pool experience significant losses,
leading to a collapse (insolvency) of the
program (see number 6).
- A group breaks up, or an individual
leaves a group, and is unable to
purchase a long-term tail.
Physicians should always have the terms of
liability coverage in writing.
4) Do I Have a Consent to Settle Clause?Asnew medical malpractice insurance
options continue to become available to
physicians, important provisions that have
traditionally been automatically included
in policies have quietly been removed for
the benefit of insurers, or insured-systems.
One such provision is a “consent-to-settle
clause,” which can be important to protect a
physician’s reputation. Some small carriers
and/ or self-insurance plans take this right
away from individual physicians, effectively
shifting control of the claims process to
either the carrier or employer. Two main
problems can occur:
- Hospitals settling a claim without a
physician’s consent, and unilaterally
apportioning a percentage to that
physician
- A carrier settling a claim without the
consent of one of its insureds, making
it reportable to the national practitioner
databank and the NJ division of
consumer affairs, and also potentially
making it more expensive to secure
coverage in the future.
Physicians should request a consent-
to-settle clause prior to signing on to a
policy when possible.
5) Is The Plan Financially Stable?Despite a history of many company failures,
medical malpractice has been a highly
profitable area of insurance over the past
few years. This revelation, along with the
relatively insignificant amount of capital
needed to start an alternative risk model
to insure physicians (e.g.captive or risk
retention group) has spawned numerous
professional liability programs. Some of
these programs have already failed.
The best way to track a program’s financial
strength is to inquire about its AM Best
(financial strength) rating. Since many new
programs do not have the financial ability
to qualify for an AM Best rating, physicians
should ask their accountants or other
advisors to review the annual financial
statements. Two common issues that occur
with financial hardship:
- Financial inability of a healthcare system
to purchase tail coverage for employed-
physicians.
- Failure of an insurance program, leaving
physicians personally liable to defend
against lawsuits.
Conclusion
The changing medical malpractice
insurance market has prompted new waves
of litigation over coverage, and much of
it involves physicians that have become
accustomed to certain protections, but
lost them because they signed on to plans
that they perhaps did not fully understand.
A little due diligence before making these
important decisions could save physicians
considerable resources down the road.
Brian S. Kern, Esq. is a co-founder
and principal with Argent Professional
Insurance Agency, LLC, the region’s
premiere professional liability insurance
agency.
16 New Jersey Physician
Industry News
medical protective to Acquire
Princeton Insurance Princeton offices & policyholder services to
remain in New Jersey…
Princeton policyholders to benefit from
Berkshire Hathaway’s unmatched financial
strength
NEW YORK & PRINCETON, N.J. & FORT
WAYNE, Ind.--(BUSINESS WIRE) -- Medical
Liability Mutual Insurance Company (MLMIC)
and Medical Protective Company (MedPro), a
Berkshire Hathaway (NYSE:BRK) subsidiary,
today announced that they have entered into a
definitive agreement for the sale of Princeton
Insurance Company, one of the Northeast’s
premiere professional liability insurers for
healthcare providers, subject to regulatory
filings, review and approvals.
“MedPro’s acquisition of Princeton, if
approved, would ensure that there is
continuity of Princeton’s medical professional
liability coverage for its current policyholders
and enable Princeton to continue its mission
in the future”
The directors and shareholders of MLMIC,
Princeton and MedPro have approved
the agreement that provides for MedPro’s
purchase of 100% ownership of Princeton
from MLMIC in an all-cash transaction. The
acquisition, which is subject to customary
closing conditions and regulatory approvals,
is expected to close in the fourth quarter of
2011.
“MedPro’s acquisition of Princeton, if
approved, would ensure that there is
continuity of Princeton’s medical professional
liability coverage for its current policyholders
and enable Princeton to continue its mission
in the future,” said MLMIC’s President,
Robert A. Menotti, M.D. “At the same time,
this transaction would maximize the value
of Princeton for our MLMIC policyholders.
Further, MLMIC would benefit by being able
to focus entirely on its commitment to New
York State healthcare providers, offering the
highest quality professional liability insurance
to physicians, dentists, hospitals, and other
healthcare providers at the lowest possible cost
consistent with long term viability. We have
been pleased with the efficient and smooth
acquisition process we have experienced
with Berkshire’s MedPro and extend our best
wishes to Princeton employees for continued
success.”
Based in Princeton, New Jersey, Princeton
Insurance employs over 100 people and
serves over 13,000 healthcare providers; it
has annualized gross written premiums of
approximately $140 million and surplus at 2nd
quarter-end of approximately $400 million.
Princeton’s principal operations would remain
in Princeton, New Jersey where it was founded
in 1975, and twenty-eight year employee
Charles Lefevre would remain as President.
Lefevre commented, “We are grateful for the
support MLMIC and their leadership have
provided to Princeton over this past decade
in our mission to serve healthcare providers.
We look forward to the enhanced product
offerings, unmatched financial strength and to
leveraging more than a century of experience
that Berkshire’s MedPro would provide to
Princeton. This transaction represents a
positive step forward in assisting healthcare
providers meet the challenges they face in
a changing healthcare environment, and a
positive step for our dedicated agents and
employees as well.”
With the industry-leading financial strength
of Berkshire’s MedPro supporting Princeton
upon the closing of the transaction, Princeton
– currently not rated by leading insurance
rater A.M. Best – is expected to apply for
financial strength ratings and be positioned
to offer additional products and services to
healthcare providers throughout the region.
Tim Kenesey, MedPro’s President and CEO,
said: “This is a win for Princeton policyholders
and agents, who would continue to enjoy the
same terrific local service long-provided by
Princeton, but would soon have the financial
strength of MedPro’s industry-leading level,
and soon have service enhancements and
additional product offerings … it is a win
for MLMIC, who enjoyed a fast and efficient
‘transaction process’ … and it is a win for
MedPro as we strengthen our Northeast
business and – importantly – enhance our
capabilities in the growing hospital segment.”
Warren Buffett, Chairman of Berkshire
Hathaway, added: “We’ve been absolutely
delighted with our acquisition of MedPro
in 2005, and look forward to MedPro
completing additional ‘add-on’ transactions
with companies – like Princeton – who
seek the world’s most stable home for their
policyholders in a very unstable and changing
healthcare liability landscape.”
Sandler O’Neill + Partners, L.P. acted as
exclusive financial advisor to MLMIC.
September 2011 17
Case I
An 88 year old white female living
in Israel developed 6 months of
daily fever and fatigue. She was
born in Poland and survived the
Nazi concentration camp. She
moved to Israel and had 4 healthy
children and 6 grandchildren one
of which was a house officer at St.
Michael’s Medical Center
The patient was a healthy
appearing, very bright woman. Her
exam was completely normal as
was her CBC, S rate, platelets, liver
test, urinalysis, blood and urine
cultures, and Brucella antibody
test. PPD negative, Total body CT
no nodes, no abnormality, CSF
negative. What is the diagnosis?
Case II
A 52 year old male electrician
complained of recurrent sinusitis
for years with increasing intensity
and pain. MRSA was cultured from
the nose but the pain continued
despite IV Vancomycin therapy.
The CT of sinuses was negative.
He was seen by many doctors
including an ENT specialist.
Nasoscope negative exam.
The white count was elevated at
15,000 with a normal differential
count. The sed rate was 88
elevated. All other lab tests were
negative including blood cultures,
cryptococcal antigen of serum
viral and bacterial nose cultures
and liver tests. IGE 800 elevated.
Allergic to grass and molds on
RAST test. Antihistimine and local
steroids were not affective. Low
dose steroids also not effective.
Desentization seems to aggravate
the sinus pain. He became
addicted to narcotic drugs. What
is the diagnosis?
Diagnosis
D I A G N O S I SFamed Infectious Disease Specialist Leon Smith, MD has suggested we start a contest. He will submit symptoms and the correct diagnosis will win a New Jersey Physician T-Shirt, as well as getting honorable mention in our column.
Please send responses to [email protected]
Rx
18 New Jersey Physician
Food for Thought
We’d always been meaning to try Arturo’s,
having read and heard great reviews. The
problem was, every time we were in Maple-
wood, to catch a movie or perhaps to just
walk through the lovely town and see where
we ended up, there was always a long line
of people waiting for a table. Last week we
made it our business to head for Maplewood
at around 5:30 PM and hope to be seated
without too much of a wait. The plan worked
better than expected. We were ushered right
in.
The place is small with seating for about
40. It was already pretty full, mostly families
with young children enjoying a pizza night
out. Arturo’s is probably best known for its
pizza, although it has received raves from
prominent critics for its authentic Italian
dishes prepared with fresh, locally produced
ingredients and those imported from Italy. In
fact, there is a tasting menu on Tuesdays and
Saturdays when Chef and owner Dan Richer
showcases his considerable talent, having
traveled to Italy to learn from the masters.
This night for us was all about the pizza. We
wanted to sample Arturo’s famous crust
made with naturally leavened pizza dough
that has been fermented for 30 hours with a
wild yeast culture and baked in a wood-burn-
ing oven. We started with an “emiliana” salad
consisting of thin slices of Arturo’s home-
cured prosciutto di parma, seasonal greens,
balsamic vinaigtette and shaved parmagiano
reggiano. We mentioned to our server that
we wished to share this and to our delight,
the salad was divided in the kitchen and
brought out on two plates.
The prociutto was divine – possibly the best
I’ve had. The greens were baby arugula,
which I always enjoy and together with the
dressing and imported cheese it all worked
beautifully. While we ate our salad I looked
around at this cozy little place and observed
young families obviously enjoying their pizza
and/or pasta and each other. There were
also tables for two like ours with a bottle
of wine or some beer brought along to ac-
company the meal. As we waited for our piz-
zas to arrive, I did notice a line developing.
There weren’t young families at this point but
rather older groups of two or four waiting to
be seated.
Arturo’s - Osteria & PizzeriaMaplewood, New JerseyBy Iris Goldberg
p Dan richer, Chef/Owner of Arturo’s Osteria in maplewood.
September 2011 19
Instead of one large pie we chose two individual pies to get a better
sampling. The first had to be the Margherita, Arturo’s most famous
pizza, with hand-made mozzarella, tomato sauce, sea salt from Italy,
fresh basil and extra virgin olive oil from Southern Italy. First, let me
describe the crust. The raves are not exaggerated. It was rustic- crisp
on the outside yet light and delicate inside. The mozzarella was su-
perb and the sauce brought me back to my young days in Brooklyn.
Our second choice was the Tartufi with home-made sausage, mush-
rooms and white truffle oil which is imported from Alba, Italy. This
was also wonderful. The meat was delicious and the white truffle oil
was a perfect complement. We were blown away by Arturo’s pizza!
In fact, I am ranking it above the pizza at Star Tavern, which was, until
now, my favorite.
Next time, we will make reservations for the tasting menu (reserva-
tions are not accepted at other times), as we are eager to try Chef
Richer’s specialties. I will definitely share that experience with our
readers. Until then, I do urge you to give Arturo’s a try whether for the
pizza or the other options. If there’s a line, brave it. I don’t think you
will be disappointed.
Arturo’s is located at 180 Maplewood Avenue, Maplewood, NJ 07040.
(973) 378-5800
p pizza margherita, the classic, made with fresh mozzarella.
p A piedmontese-style fresh pasta with meat ragu, shaved parmigiano-reggiano.
p panna Cotta for dessert.
p Fresh pasta being tossed in the hearth.
20 New Jersey Physician
Hospital Rounds
New Chief Medical Officer Named at The Cancer Institute of New Jersey Montgomery Township Resident Tapped for Leadership Post
A Belle Mead (Somerset
County) resident has
been named the new
chief medical officer
at The Cancer Institute
of New Jersey (CINJ).
Deborah L. Toppmeyer, MD, an associate
professor of medicine at UMDNJ-Robert
Wood Johnson Medical School, was
recently appointed by CINJ Director
Robert S. DiPaola, MD. CINJ is a Center
of Excellence of UMDNJ-Robert Wood
Johnson Medical School.
Dr. Toppmeyer joined CINJ in 1995 from
the Dana Farber Cancer Institute at Harvard
Medical School. She is an expert in breast
cancer, breast cancer genetics and the
design and implementation of clinical
trials that offer promising new therapies
targeted to specific types of breast cancer.
As chief medical officer, she will be
responsible for compliance with all clinical
medical policies, regulations and clinical
performance standards of the state, the
federal government, and accrediting bodies.
She will have oversight and responsibility
for all of CINJ’s clinical objectives and serve
as CINJ’s ultimate authority on medical
issues.
Through her role as director both of CINJ’s
Stacy Goldstein Breast Cancer Center and
of the LIFE (LPGA pros In the Fight to
Eradicate breast cancer) Center, Toppmeyer
helps patients navigate through treatment
options while encouraging enrollment in
clinical trials. She is also the chief of solid
tumor oncology at CINJ.
“Over the past 16 years, Dr. Toppmeyer has
played an integral role in the advancement
and success of CINJ. As a renowned
researcher and clinician, Dr. Toppmeyer
has drawn upon and shared that wealth of
experience in order to successfully meet
the needs of patients while growing CINJ
clinic operations and clinical trial accrual.
I have every confidence that in her new
role, she will help move CINJ forward in an
even greater capacity,” noted Dr. DiPaola,
a professor of medicine at UMDNJ-Robert
Wood Johnson Medical School.
Toppmeyer is the author or co-author of
more than 40 publications and serves on
the editorial board of the journal Clinical
Cancer Research. She also serves as a
core member for the Breast Committee
of the Eastern Cooperative Oncology
Group, which is one of the nation’s largest
clinical cancer research organizations that
conducts clinical trials in all types of adult
cancers.
About The Cancer Institute of New JerseyThe Cancer Institute of New Jersey (www.
cinj.org) is the state’s first and only National
Cancer Institute-designated Comprehensive
Cancer Center dedicated to improving the
detection, treatment and care of patients
with cancer, and serving as an education
resource for cancer prevention. CINJ’s
physician-scientists engage in translational
research, transforming their laboratory
discoveries into clinical practice, quite
literally bringing research to life. To make a
tax-deductible gift to support CINJ, call 732-
235-8614 or visit www.cinjfoundation.org.
CINJ is a Center of Excellence of UMDNJ-
Robert Wood Johnson Medical School.
Follow us on Facebook at www.facebook.
com/TheCINJ.
The CINJ Network is comprised of hospitals
throughout the state and provides the
highest quality cancer care and rapid
dissemination of important discoveries
into the community. Flagship Hospital:
Robert Wood Johnson University Hospital.
System Partner: Meridian Health (Jersey
Shore University Medical Center, Ocean
Medical Center, Riverview Medical Center,
Southern Ocean Medical Center, and
Bayshore Community Hospital). Major
Clinical Research Affiliate Hospitals: Carol
G. Simon Cancer Center at Morristown
Medical Center, Carol G. Simon Cancer
Center at Overlook Medical Center, and
Cooper University Hospital. Affiliate
Hospitals: CentraState Healthcare System,
JFK Medical Center, Mountainside Hospital,
Robert Wood Johnson University Hospital
Hamilton (CINJ Hamilton), Somerset
Medical Center, The University Hospital/
UMDNJ-New Jersey Medical School*, and
University Medical Center at Princeton.
*Academic Affiliate
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